1.1 Field of the Invention
The present invention relates to compositions and methods of topically treating pain caused by swelling or inflammation of the fascia, ligaments or tendons of a mammal. Specifically, the present invention relates to compositions and methods of topically treating pain in the foot caused by swelling or inflammation of the fascia, ligaments or tendons of the foot of a person in need of treatment, thereof, e.g. plantar fasciitis.
1.2 Prior Art
Lidocaine may be topically applied to the skin as an anesthetic to reduce pain. Derry S. Wiffen, P J, Moore R A, and Quinlan J. Cochrane1 reported twelve topical studies using a 5% medicated patch, a 5% cream, a 5% gel, and an 8% spray to treat pain. These 12 studies (totaling 508 participants) used comparisons with placebo or an active control. Six studies enrolled participants with moderate or severe postherpetic neuralgia, and the remaining studies enrolled different, or mixed, neuropathic pain conditions, including trigeminal neuralgia and postsurgical or post-traumatic neuralgia. There was no first or second tier evidence, and no pooling of data was possible for efficacy outcomes. Only one multiple-dose study reported a primary outcome of participants with ≥50% or ≥30% pain intensity reduction. Three single-dose studies reported participants who were pain-free at a particular time point, or had a 2-point (of 10) reduction in pain intensity. The two enriched enrolment, randomised withdrawal studies reported time to loss of efficacy. In all but one study, third tier (very low quality) evidence indicated that lidocaine was better than placebo for some measure of pain relief.
Therefore, there is a need for improved treatments of pain, e.g., pain caused by swelling or inflammation of the fascia, ligaments or tendons of a person in need of treatment.